Celltrion announced on April 11 that “Zymfentra” (the U.S. brand name for Remsima), the world’s first subcutaneous formulation of infliximab for the treatment of autoimmune diseases developed in-house, has completed its formulation patent registration with the United States Patent and Trademark Offi
Celltrion announced on Feb. 6 that Rani Therapeutics (Rani) in the United States has confirmed positive topline results in the Phase 1 clinical trial of oral ustekinumab (development name: RT-111). RT-111 is an oral formulation of Celltrion’s Stelara biosimilar, CT-P43, currently under development.I
On Dec. 28, the integrated company Celltrion will be officially launched. Celltrion is taking steps to leap into a global big pharmaceutical firm by merging with Celltrion Healthcare, which is responsible for global distribution.Celltrion and Celltrion Healthcare announced on Dec. 27 that they are i
As the patent for the blockbuster pharmaceutical “Stelara,” which generated more than 23 trillion won (US$17.1 billion) in global sales last year, approaches expiration, domestic biosimilar developers are consistently announcing their clinical trial results. Biosimilars refer to replica drugs develo
Celltrion announced on Sept. 4 that it recently obtained sales approval for its Avastin (bevacizumab) biosimilar Vegzelma from the Australian Therapeutic Goods Administration (TGA).Celltrion has been granted sales approval for Vegzelma in Australia for the entire range of indications approved for Av
On Aug. 17, Celltrion Inc. announced its decision to merge with Celltrion Healthcare Co. Through its disclosure, Celltrion explained that the decision to merge was made to integrate assets for large-scale investments, enhance cost competitiveness through the integration of development, production, a
Samsung Bioepis is said to be reviewing the acquisition of the biosimilar business unit of U.S. biotech firm Biogen.According to the biotech industry on Aug. 2, Samsung Bioepis is considering acquiring Biogen’s biosimilar business unit, which has recently been put up for sale.Biogen has been a colla
Companies investing in biopharmaceutical-related technologies and production facilities will now be eligible for a maximum tax deduction of 35 percent.On July 27, the Ministry of Economy and Finance held the 56th session of the Tax System Advancement Review Committee presided over by Deputy Prime Mi
Samsung Bioepis' Humira biosimilar Hadlima (sold by Organon) has successfully been listed in the formulary recommendations list of U.S. Pharmacy Benefit Management (PBM) company Prime Therapeutics.On July 12 (local time), Prime Therapeutics announced its formulary recommendations list for Humira
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.Although SK Biopharm’s operating losses likely narrowed q-q in 2Q23, we believe that COGS-to-sales ratio returned to the previous high level, and SG&A expenses likely upped q-q on clinical costs. How
On July 1 (local time), the U.S. Humira biosimilar market, worth 24 trillion won a year, opened. In the first week alone, six Korean and foreign companies plan to launch their products.According to sources in the biotech industry on July 2, Samsung Bioepis launched Hadlima, a Humira biosimilar, in t
Samsung Bioepis's biosimilar Renflexis, SK Biopharmaceuticals' epilepsy drug Xcopri, and Daewoong Pharmaceutical's botulinum toxin Nabota, are expected to exceed US$200 million in U.S. sales this year.The Renflexis sales added up to US$196 million last year. According to industry sources
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed.Top pick for Pharmaceuticals & Biotechnology We maintain BUY and TP of KRW1,200,000 on Samsung Biologics. Our TP remains unchanged despite revisions to 2023 ERP and RFR and slight downward adjustments to earnin
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed.We expect Celltrion to post 4Q22 OP of W187.8bn, remaining roughly in line with our estimate, but missing consensus. The firm should report steady growth in 2023, backed by additional sales of Remsima
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed.US market prescription trends proved stable m-m in December. The US market shares of most domestic biosimilar players have been widening as of late, but further decline in their ASPs is being seen in
The sale of Humira biosimilars in the United States is scheduled to start next month. This market is expected to be as huge as US$17.3 billion. More than 10 global biopharmaceutical companies are focusing on it, including Amgen, Samsung Bioepis, and Celltrion. Samsung Bioepis' biosimilar will be
Aprogen has joined a race to take over a current good manufacturing practice (cGMP) production facility in North Carolina of the United States. The move reflects its strategy to quickly advance into the U.S. market in response to U.S. President Joe Biden’s policy to favor U.S.-made biotech products.
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed. Maintain BUY, target price of KRW1,200,000 We maintain BUY and TP of KRW1,200,000 on Samsung Biologics. Our investment highlights are (1) 3Q22 earnings beat, (2) secured growth drivers via the recent start of
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed. Maintain BUY, target price of KRW1,200,000 We maintain BUY and TP of KRW1,200,000 on Samsung Biologics. The stock deserves attention because (1) 3Q22 earnings should beat the market consensus, (2) growth momen
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. The US biosimilar market is set to expand in earnest next year. In response, the Celltrion Group plans to deploy a direct selling strategy in the US. While initial cost burden is worrisome, we expect